Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 05, 2016 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
Entity Central Index Key | 786,947 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | ACUR | |
Entity Common Stock, Shares Outstanding | 11,833,801 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets | ||
Cash and cash equivalents | $ 3,265 | $ 2,485 |
Marketable securities (Note 7) | 3,516 | 10,837 |
Accounts receivable, net of allowances of $4 and $91 | 211 | 83 |
Accrued investment income | 13 | 37 |
Inventories, net (Note 8) | 182 | 276 |
Prepaid expenses and other current assets | 491 | 417 |
Total current assets | 7,678 | 14,135 |
Property, plant and equipment, net (Note 9) | 1,009 | 1,013 |
Intangible asset, net of accumulated amortization of $465 and $362 (Note 4) | 1,535 | 1,638 |
Other assets | 0 | 175 |
Total assets | 10,222 | 16,961 |
Current liabilities | ||
Accounts payable | 164 | 110 |
Accrued expenses (Note 10) | 804 | 564 |
Accrued interest | 49 | 0 |
Other current liabilities | 34 | 45 |
Sales returns liability | 263 | 205 |
Debt - current (Note 11) | 2,629 | 2,320 |
Total current liabilities | 3,943 | 3,244 |
Debt - non-current portion, net of discount of $142 and $193, and debt issuance costs of $70 and $97 (Note 11) | 4,165 | 5,430 |
Accrued interest - non-current portion | 477 | 387 |
Total liabilities | 8,585 | 9,061 |
Commitments and contingencies (Note 17) | ||
Stockholders’ equity | ||
Common stock - $.01 par value per share; 100,000 shares authorized, 11,834 and 11,801 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 118 | 118 |
Additional paid-in capital | 375,475 | 375,157 |
Accumulated deficit | (373,982) | (367,310) |
Accumulated other comprehensive income (loss) | 26 | (65) |
Total stockholders’ equity | 1,637 | 7,900 |
Total liabilities and stockholders’ equity | $ 10,222 | $ 16,961 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Accounts receivable, net of allowances | $ 4 | $ 91 |
Finite-lived intangible assets accumulated amortization | 465 | 362 |
Long-term debt, net of debt discount | 142 | 193 |
Debt Instrument Issuance Cost | $ 70 | $ 97 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 11,834 | 11,801 |
Common stock, shares outstanding | 11,834 | 11,801 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenues: | ||||
License fee revenue | $ 0 | $ 250 | $ 0 | $ 5,250 |
Collaboration revenue | 133 | 0 | 233 | 0 |
Royalty revenue | 30 | 0 | 47 | 0 |
Product sales, net | 94 | 91 | 201 | 448 |
Total revenues, net | 257 | 341 | 481 | 5,698 |
Cost and expenses: | ||||
Cost of sales (excluding inventory write-downs) | 99 | 98 | 201 | 422 |
Inventory write-downs (Note 8) | 26 | 47 | 26 | 307 |
Research and development | 1,403 | 511 | 2,417 | 1,475 |
Selling, marketing, general and administrative | 1,808 | 2,083 | 4,054 | 4,380 |
Total costs and expenses | 3,336 | 2,739 | 6,698 | 6,584 |
Operating loss | (3,079) | (2,398) | (6,217) | (886) |
Non-operating income (expense): | ||||
Investment income | 21 | 36 | 48 | 71 |
Interest expense (Note 11) | (233) | (301) | (482) | (609) |
Other income (expense) | 3 | 0 | (21) | 0 |
Total other expense, net | (209) | (265) | (455) | (538) |
Loss before provision for income taxes | (3,288) | (2,663) | (6,672) | (1,424) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | (3,288) | (2,663) | (6,672) | (1,424) |
Other comprehensive income (loss): | ||||
Unrealized gains (losses) on securities | 21 | (31) | 91 | 0 |
Comprehensive loss | $ (3,267) | $ (2,694) | $ (6,581) | $ (1,424) |
Loss per share of common stock: | ||||
Basic | $ (0.28) | $ (0.27) | $ (0.56) | $ (0.15) |
Diluted | $ (0.28) | $ (0.27) | $ (0.56) | $ (0.15) |
Weighted average common shares outstanding: | ||||
Basic | 11,858 | 9,847 | 11,847 | 9,820 |
Diluted | 11,858 | 9,847 | 11,847 | 9,820 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - 6 months ended Jun. 30, 2016 - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional paid-in capital | Accumulated deficit | Accumulated Other Comprehensive Income (Loss) |
Balance at Dec. 31, 2015 | $ 7,900 | $ 118 | $ 375,157 | $ (367,310) | $ (65) |
Balance (in shares) at Dec. 31, 2015 | 11,801 | ||||
Net loss | (6,672) | $ 0 | 0 | (6,672) | 0 |
Other comprehensive income | 91 | 0 | 0 | 0 | 91 |
Share-based compensation | 300 | 0 | 300 | 0 | 0 |
Net distribution of common stock pursuant to restricted stock unit award plan | 18 | $ 0 | 18 | 0 | 0 |
Net distribution of common stock pursuant to restricted stock unit award plan (in shares) | 33 | ||||
Balance at Jun. 30, 2016 | $ 1,637 | $ 118 | $ 375,475 | $ (373,982) | $ 26 |
Balance (in shares) at Jun. 30, 2016 | 11,834 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (6,672) | $ (1,424) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 67 | 59 |
Provision to reduce inventory to net realizable value | 26 | 307 |
Provision for sales returns | 58 | 195 |
Share-based compensation | 300 | 311 |
Amortization of debt discount and deferred debt issue costs | 78 | 97 |
Amortization of bond premium in marketable securities | 29 | 76 |
Amortization of intangible asset | 103 | 103 |
Loss on sales of marketable securities | 21 | 0 |
Loss on disposal of property, plant and equipment | 0 | 20 |
Changes in assets and liabilities: | ||
Accounts receivable, net | (128) | (33) |
Accrued investment income | 24 | 13 |
Inventories | 68 | (220) |
Prepaid expenses and other current assets | (74) | (152) |
Other current deferred assets | 0 | 215 |
Other assets | 175 | (175) |
Accounts payable | 54 | 44 |
Accrued expenses | 240 | 295 |
Deferred revenue | 0 | (353) |
Accrued interest - current and long term | 139 | 96 |
Other current liabilities | 7 | 23 |
Net cash used in operating activities | (5,485) | (503) |
Cash Flows from Investing Activities: | ||
Proceeds from sale and maturities of marketable securities | 7,362 | 1,595 |
Proceeds from disposals of property, plant and equipment | 0 | 14 |
Additions to property, plant and equipment | (63) | (257) |
Net cash provided by investing activities | 7,299 | 1,352 |
Cash Flows from Financing Activities: | ||
Proceeds from distribution of restricted stock units | 0 | 1 |
Proceeds from ATM offering | 0 | 225 |
ATM offering transaction costs | 0 | (8) |
Principal payments on debt | (1,034) | (573) |
Net cash used in financing activities | (1,034) | (355) |
Net increase in cash and cash equivalents | 780 | 494 |
Cash and cash equivalents at beginning of year | 2,485 | 774 |
Cash and cash equivalents at end of period | 3,265 | 1,268 |
Cash paid during the year for: | ||
Interest | $ 265 | $ 414 |
CONSOLIDATED STATEMENTS OF CAS7
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Supplemental Disclosure of Noncash Financing Activities: | ||
Class of Warrant or Right, Outstanding | 60 | |
Additions To Debt Instrument Unamortized Discount | $ 0 | $ 33 |
Maximum [Member] | ||
Supplemental Disclosure of Noncash Financing Activities: | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.98 | |
Minimum [Member] | ||
Supplemental Disclosure of Noncash Financing Activities: | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 6 Months Ended |
Jun. 30, 2016 | |
Description Of Business Disclosure [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1 - DESCRIPTION OF BUSINESS Acura Pharmaceuticals, Inc., a New York corporation, and its subsidiary (the “Company”, “We”, “Us” or “Our”) is a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and products intended to address medication abuse and misuse. We have discovered and developed three proprietary platform technologies which can be used to develop multiple products. Our Aversion® and Limitx Technologies are intended to address methods of abuse associated with opioid analgesics while our Impede® Technology is directed at minimizing the extraction and conversion of pseudoephedrine into methamphetamine. ⋅ Oxaydo® Tablets (oxycodone HCl, CII), which utilizes the Aversion Technology, is the first and only approved immediate-release oxycodone product in the United States with abuse deterrent labeling. On January 7, 2015, we entered into a Collaboration and License Agreement with Egalet US, Inc. and Egalet Ltd., each a subsidiary of Egalet Corporation (collectively, “Egalet”) pursuant to which we exclusively licensed to Egalet worldwide rights to manufacture and commercialize Oxaydo®. Oxaydo is currently approved by the FDA for marketing in the United States in 5mg and 7.5mg strengths. Egalet launched Oxaydo in the United States late in the third quarter of 2015. ⋅ Nexafed® Tablets (30mg pseudoephedrine) and Nexafed® Sinus Pressure + Pain Tablets (30/325mg pseudoephedrine and acetaminophen), utilizing the Impede Technology, were launched by us into the United States market in December 2012 and February 2015, respectively. We have multiple pseudoephedrine products in development utilizing our Impede Technology. On June 15, 2015, we and Bayer Healthcare LLC entered into a License and Development Agreement pursuant to which we granted Bayer an exclusive worldwide license to our Impede Technology for use in an undisclosed methamphetamine resistant pseudoephedrine containing product and providing for the joint development of such product using our Impede Technology for the U.S. market. ⋅ Our third abuse deterrent technology, Limitx, is designed to retard the release of active drug ingredients when too many tablets are accidently or purposefully ingested. We have completed our first clinical study, Study AP-LTX-400, of our lead Limitx immediate release oral abuse deterrent drug candidate using the opioid hydromorphone HCI (LTX-04). Study AP-LTX-400, or Study 400, was a two cohort, open label, crossover design pharmacokinetic study in healthy adult subjects. The FDA has designated the development program for LTX-04 as Fast Track, which is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. On April 13, 2016 and June 8, 2016, we announced that topline interim results from cohorts 1 and 2, respectively, of Study 400 for one test formulation of LTX-04 successfully demonstrated the release of the active opioid ingredient was reduced when three or more tablets were ingested, but that additional formulation development will be required for LTX-04 to deliver a sufficient amount of the active ingredient when one or two tablets are administered. We are also developing an immediate-release hydrocodone bitartrate with acetaminophen product utilizing our Limitx Technology. Amounts presented have been rounded to the nearest thousand, where indicated, except share and per share data. The equity amounts and all share and per share data of the Company have been retroactively adjusted to reflect a one-for-five reverse stock split effected by us on August 28, 2015. |
LIQUIDITY MATTERS
LIQUIDITY MATTERS | 6 Months Ended |
Jun. 30, 2016 | |
LIQUIDITY MATTERS [Abstract] | |
LIQUIDITY MATTERS | NOTE 2 LIQUIDITY MATTERS The accompanying financial statements have been prepared assuming the Company will continue as a going concern. At June 30, 2016, we had unrestricted cash, cash equivalents and marketable securities (after deduction of a $ 2.5 4.3 1.2 374.0 6.2 6.7 We estimate that our current unrestricted cash, cash equivalent and marketable securities will be sufficient to fund the development of our products utilizing our Limitx and Impede Technologies, the commercialization of our Nexafed products and our related operating expenses through November 2016 while maintaining compliance with the $2.5 million compensating balance requirement under our term loan with Oxford Finance LLC. At August 5, 2016, we had unrestricted cash, cash equivalents and marketable securities (after deduction of the $2.5 million compensating balance requirement under our term loan with Oxford) of $ 3.4 In view of the matters described above, recoverability of a major portion of the recorded asset amounts shown in the Company’s accompanying balance sheets is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its financing requirements on a continuous basis, to maintain existing financing and to succeed in its future operations. The Company’s financial statements do not include any adjustment relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence. |
ACCOUNTING PRONOUNCEMENTS
ACCOUNTING PRONOUNCEMENTS | 6 Months Ended |
Jun. 30, 2016 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
ACCOUNTING PRONOUNCEMENTS | NOTE 3 ACCOUNTING PRONOUNCEMENTS Revenue from Contracts with Customers In May 2014 the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) ASU No. 2014-09, “ Revenue from Contracts with Customers (Topic 606) “Revenue Recognition In addition, in March 2016, the FASB issued ASU Update 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients Revenue Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission of SEC Guidance Because of Accounting Standards Updates 2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016 EITF Meeting Revenue from Contracts with Customers (Topic 606) The amendments in ASU 2016-08 clarify how an entity should identify the specified good or service for the principal versus agent evaluation and how it should apply the control principle to certain types of arrangements. ASU 2016-10 clarifies the following two aspects of ASU 2014-09: identifying performance obligations and licensing implementation guidance. ASU 2016-11 rescinds several SEC Staff Announcements that are codified in Topic 605, including, among other items, guidance relating to accounting for consideration given by a vendor to a customer, as well as accounting for shipping and handling fees and freight services. ASU 2016-12 provides clarification to Topic 606 on how to assess collectability, present sales tax, treat noncash consideration, and account for completed and modified contracts at the time of transition. In addition, ASU 2016-12 clarifies that an entity retrospectively applying the guidance in Topic 606 is not required to disclose the effect of the accounting change in the period of adoption. The effective date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU 2014-09, which is effective for fiscal years, and for interim periods within those years, beginning after December 15, 2018. The Company is currently assessing the impact of these ASUs on its results of operations, cash flows or financial condition. Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In August 2014, the FASB issued ASU No. 2014-15, “ Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern |
LICENSE, DEVELOPMENT, AND COMME
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS | 6 Months Ended |
Jun. 30, 2016 | |
Research and Development Disclosure [Abstract] | |
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENT | NOTE 4 - LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS Egalet Agreement On January 7, 2015, we and Egalet entered into a Collaboration and License Agreement (the “Egalet Agreement”) to commercialize Aversion Oxycodone (formerly known as Oxecta®) under our tradename Oxaydo. Oxaydo is approved by the FDA for marketing in the United States in 5 mg and 7.5 mg strengths. Under the terms of the Egalet Agreement, we transferred the approved New Drug Application, or NDA, for Oxaydo to Egalet and Egalet is granted an exclusive license under our intellectual property rights for development and commercialization of Oxaydo worldwide (the “Territory”) in all strengths, subject to our right to co-promote Oxaydo in the United States. Eaglet launched Oxaydo in the United States late in the third quarter of 2015. In accordance with the Egalet Agreement, we and Egalet have formed a joint steering committee to coordinate commercialization strategies and the development of product line extensions. Egalet will pay a significant portion of the expenses and we will pay for the remaining costs relating to (i) annual NDA PDUFA product fees, (ii) expenses of the FDA required post-marketing study for Oxaydo and (iii) expenses of clinical studies for product line extensions (additional strengths) of Oxaydo for the United States and Egalet will bear all of the expenses of development and regulatory approval of Oxaydo for sale outside the United States. Egalet is responsible for all manufacturing and commercialization activities in the Territory for Oxaydo. Subject to certain exceptions, Egalet will have final decision making authority with respect to all development and commercialization activities for Oxaydo, including pricing, subject to our co-promotion right. Egalet may develop Oxaydo for other countries and in additional strengths, in its discretion. Egalet paid us a $ 5.0 2.5 one-time $12.5 million milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year. The Egalet Agreement expires upon the expiration of Egalet’s royalty payment obligations in all countries. Either party may terminate the Egalet Agreement in its entirety if the other party breaches a payment obligation, or otherwise materially breaches the Egalet Agreement, subject to applicable cure periods, or in the event the other party makes an assignment for the benefit of creditors, files a petition in bankruptcy or otherwise seeks relief under applicable bankruptcy laws. We also may terminate the Egalet Agreement with respect to the U.S. and other countries if Egalet materially breaches its commercialization obligations. Egalet may terminate the Egalet Agreement for convenience on 120 days prior written notice, which termination may not occur prior to the second anniversary of Egalet’s launch of Oxaydo. Termination does not affect a party’s rights accrued prior thereto, but there are no stated payments in connection with termination other than payments of obligations previously accrued. For all terminations (but not expiration), the Egalet Agreement provides for the transition of development and marketing of Oxaydo from Egalet to us, including the conveyance by Egalet to us of the trademarks and all regulatory filings and approvals relating to Oxaydo, and for Egalet’s supply of Oxaydo for a transition period. Bayer Agreement On June 15, 2015, we and Bayer entered into a License and Development Agreement (the “Bayer Agreement”) granting Bayer an exclusive worldwide license to our Impede Technology for use in an undisclosed methamphetamine resistant pseudoephedrinecontaining product (the “Bayer Licensed Product”) and providing for the joint development of such product utilizing our Impede Technology for the U.S. market. The Bayer Agreement also grants Bayer first right to negotiate a license to the Impede Technology for certain other products. We and Bayer have formed a joint development committee to coordinate development of the Bayer Licensed Product. We will be eligible to receive reimbursement of certain of our development costs, success-based development and regulatory milestones payments, and low mid-single digit royalties on net sales of the Bayer Licensed Product in countries with patent coverage and a reduced royalty elsewhere. The term of the Bayer Agreement with respect to each country expires when royalties are no longer payable with respect to such country. After expiration of the term Bayer retains a license to sell the Bayer Licensed Product on a royalty free basis. Either party may terminate the Bayer Agreement in its entirety if the other party materially breaches the Bayer Agreement, subject to an applicable cure period, or in the event the other party makes an assignment for the benefit of creditors, files a petition in bankruptcy or otherwise seeks relief under applicable bankruptcy laws. Bayer may terminate the Bayer Agreement immediately prior to completion of our development obligations or at any time upon six (6) months prior written notice thereafter. We may terminate the Bayer Agreement with respect to the U.S. if Bayer ceases or suspends development or commercialization of the Bayer Licensed Product for a certain period of time. Purdue Pharma The Company received a $ 250 Terminated Pfizer Agreement In 2007, we entered into License, Development and Commercialization Agreement for Oxaydo (named Oxecta® under a Pfizer trademark) and other Aversion opioid development products with King Pharmaceuticals Research and Development, Inc., which became a subsidiary of Pfizer in 2011 (the “Pfizer Agreement”). In April 2014, we entered into a letter agreement with Pfizer providing for the termination of the Pfizer Agreement and the return to us of Oxaydo and all Aversion product rights in exchange for a one-time termination payment of $ 2.0 2.0 103 260 260 |
REVENUE RECOGNITION
REVENUE RECOGNITION | 6 Months Ended |
Jun. 30, 2016 | |
Revenue Recognition [Abstract] | |
REVENUE RECOGNITION | NOTE 5 - REVENUE RECOGNITION License Fee Revenue On January 7, 2015, we and Egalet entered into a Collaboration and License Agreement to commercialize Oxaydo tablets (formerly known as Oxecta) utilizing our Aversion® Technology. Egalet paid us $ 5.0 Collaboration Revenue Collaboration revenue is derived from reimbursement of development expenses, such as under the Bayer Agreement, and are recognized when costs are incurred pursuant to the agreement. The ongoing research and development services being provided under the collaboration are priced at fair value based upon the reimbursement of labor and expenses incurred pursuant to the collaboration agreements. During the three and six month periods ended June 30, 2016, we recognized collaboration revenue of $ 133 233 Royalty Revenue In connection with our Collaboration and License Agreement with Egalet to commercialize Oxaydo tablets we will receive a stepped royalty at percentage rates ranging from mid-single digits to double-digits based on Oxaydo net sales during each calendar year over the term of the agreement (excluding net sales resulting from any co-promotion efforts by us). We recognize royalty revenue each calendar quarter based on net sales reported to us by Egalet in accordance with the agreement. Egalet’s first commercial sale of Oxaydo occurred in October 2015. We recognized royalty revenue of $ 30 47 Product Sales Nexafed was launched in mid-December 2012 and Nexafed Sinus Pressure + Pain was launched in February 2015. We sell our Nexafed products in the United States to wholesale pharmaceutical distributors as well as directly to chain drug stores. Our Nexafed products are sold subject to the right of return usually for a period of up to twelve months after the product expiration. The Nexafed products currently have a shelf life of twenty-four months from the date of manufacture. Given the limited sales history of our Nexafed products, we could not reliably estimate expected returns of the product at the time of shipment to certain customers. During the first quarter of 2015, we determined we had obtained sufficient sales returns history to reasonably estimate future product returns from those customers. We recorded a one-time adjustment in the first quarter of 2015 to recognize revenue that had previously been deferred, resulting in additional net revenues of $ 314 120 255 263 205 Shipping and Handling Costs We record shipping and handling costs in selling expenses. The amounts recorded to selling expenses from the shipments of the Nexafed product line during each of the six month periods ended June 30, 2016 and 2015 were not material. |
RESEARCH AND DEVELOPMENT ACTIVI
RESEARCH AND DEVELOPMENT ACTIVITIES | 6 Months Ended |
Jun. 30, 2016 | |
Research and Development [Abstract] | |
RESEARCH AND DEVELOPMENT ACTIVITIES | NOTE 6 - RESEARCH AND DEVELOPMENT ACTIVITIES Research and Development (“R&D”) expenses may include internal R&D activities, external Contract Research Organization (“CRO”) services and their clinical research sites, and other activities. Internal R&D activity expenses may include facility overhead, equipment and facility maintenance and repairs, laboratory supplies, pre-clinical laboratory experiments, depreciation, salaries, benefits, and share-based compensation expenses. CRO activity expenses may include preclinical laboratory experiments and clinical trial studies. Other activity expenses may include regulatory services and consulting including our cost sharing expenses of clinical studies for product line extensions (additional strengths) of Oxaydo for the United States under the Egalet Agreement and our cost sharing expenses of the FDA required post-marketing study for Oxaydo under the Egalet Agreement, and regulatory legal counsel. Internal R&D activities and other activity expenses are charged to operations as incurred. We make payments to the CRO's based on agreed upon terms and may include payments in advance of a study starting date. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the stage of completion of a study as provided by the CRO. Accrued CRO costs are subject to revisions as such studies progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. During December 2015, we entered into a $ 200 65 200 |
INVESTMENTS IN MARKETABLE SECUR
INVESTMENTS IN MARKETABLE SECURITIES | 6 Months Ended |
Jun. 30, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENTS IN MARKETABLE SECURITIES | NOTE 7 - INVESTMENTS IN MARKETABLE SECURITIES June 30, 2016 December 31, 2015 (in millions) (in millions) Marketable securities: Corporate bonds - maturing within 1 year $ 1.3 $ 3.1 Corporate bonds - maturing after 1 year and less than two years - 0.4 Exchange-traded funds 2.2 7.3 Total marketable securities $ 3.5 $ 10.8 The Company’s marketable securities are classified as available-for-sale and are recorded at fair value based on quoted market prices or net asset value using the specific identification method. The purchase cost of corporate bonds may include a purchase price premium or discount which will be amortized or accreted against earned interest income to the maturity date of the bond. Our investments are classified as current in the Company’s Consolidated Balance Sheets as they may be sold within one year in response to changes in market prices or interest rates, to realign our investment concentrations or to meet our working capital needs. June 30, 2016 (in millions) Cost Gross Gross Fair Available-for-sale: Corporate bonds $ 1.3 $ - $ - $ 1.3 Exchange-traded funds 2.2 - - 2.2 Total - Current $ 3.5 $ - $ - $ 3.5 December 31, 2015 (in millions) Cost Gross Gross Fair Available-for-sale: Corporate bonds $ 3.6 $ - $ (0.1) $ 3.5 Exchange-traded funds 7.3 - - 7.3 Total - Current $ 10.9 $ - $ (0.1) $ 10.8 Fair Value Measurement Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants. Fair values determined based on Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined based on Level 2 inputs utilize observable quoted prices for similar assets and liabilities in active markets and observable quoted prices for identical or similar assets in markets that are not very active. Fair values determined based on Level 3 inputs utilize unobservable inputs and include valuations of assets or liabilities for which there is little, if any, market activity. A financial asset or liability’s classification within the above hierarchy is determined based on the lowest level input that is significant to the fair value measurement. June 30, 2016 (in millions) Total Level 1 Level 2 Level 3 Assets: Corporate bonds $ 1.3 $ - $ 1.3 $ - Exchange-traded funds 2.2 2.2 - - Total $ 3.5 $ 2.2 $ 1.3 $ - December 31, 2015 (in millions) Total Level 1 Level 2 Level 3 Assets: Corporate bonds $ 3.5 $ - $ 3.5 $ - Exchange-traded funds 7.3 7.3 - - Total $ 10.8 $ 7.3 $ 3.5 $ - Accumulated Other Comprehensive Income (Loss) Unrealized gains or losses on marketable securities are recorded in accumulated other comprehensive income (loss). Accumulated other comprehensive income (loss) at June 30, 2016 consisted of unrealized gains on securities of $ 26 65 |
INVENTORIES
INVENTORIES | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | NOTE 8 INVENTORIES Inventories consist of raw materials and finished goods on our Nexafed product at June 30, 2016. Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable value). We write down inventories to net realizable value based on forecasted demand and market conditions, which may differ from actual results. Our purchases of ingredients and other materials required in our development and clinical trial activities are expensed as incurred. June 30, December 31, 2016 2015 (in thousands) Raw and packaging materials $ 98 $ - Finished goods 116 346 Total 214 346 Less: reserve for finished goods (32) (70) Net inventory $ 182 $ 276 2016 2015 (in thousands) Reserve balance at January 1, $ 70 $ - Reserve expense raw and packaging materials - 260 Reserve expense finished goods 26 47 96 307 Inventory destruction raw and packaging materials - (260) Inventory destruction - finished goods (64) - Reserve balance at June 30, $ 32 $ 47 |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 6 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 9 PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment are stated at cost of $ 2,817 2,754 1,808 1,741 Our depreciation expense was $ 68 59 Building and improvements 10 - 40 years Land and improvements 20 - 40 years Machinery and equipment 7 - 10 years Scientific equipment 5 - 10 years Computer hardware and software 3 - 10 years |
ACCRUED EXPENSES
ACCRUED EXPENSES | 6 Months Ended |
Jun. 30, 2016 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 10 - ACCRUED EXPENSES June 30, December 31, 2016 2015 (in thousands) Payroll, payroll taxes, and benefits $ 132 $ 101 Professional services 149 171 Franchise taxes 6 6 Property taxes 15 15 Marketing and promotion 40 115 Clinical, non-clinical and regulatory services 121 92 Cost sharing expenses 278 - Other fees and services 63 64 Total $ 804 $ 564 |
DEBT
DEBT | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 11 DEBT On December 27, 2013, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford” or the “Lender”), for a term loan to the Company in the principal amount of $ 10.0 8.35 13.35 260 December 1, 2018 3.0 7.0 60 7.98 400 December 27, 2020 Expected dividend yield 0.0 % Risk-free interest rate 2.4 % Expected volatility 92 % Expected term (years) 7 On January 7, 2015, we and Oxford entered into an amendment to the Loan Agreement. Pursuant to the amendment, (i) the exercise price of the Warrants was lowered from $ 7.98 2.52 33 2.5 5.0 The Company may voluntarily prepay the Term Loan in full, but not in part, and any prepayment is subject to a prepayment premium equal to 1 795 477 The Company was obligated to pay customary lender fees and expenses, including a one-time facility fee of $ 50 100 231 10.16 The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, limits or restrictions on the Company’s ability to incur liens, incur indebtedness, pay dividends, redeem stock, and merge or consolidate and dispose of assets. In addition, it contains customary events of default that entitles the Lender to cause any or all of the Company’s indebtedness under the Loan Agreement to become immediately due and payable. The events of default (some of which are subject to applicable grace or cure periods), include, among other things, nonpayment defaults, covenant defaults, a material adverse change in the Company, bankruptcy and insolvency defaults and material judgment defaults. Long-term Debt Current Long-term Total Balance at Dec 31, 2015 $ 2,320 $ 5,720 $ 8,040 Principal payments (1,034) - (1,034) Classification 1,343 (1,343) - Balance at June 30, 2016 $ 2,629 $ 4,377 $ 7,006 Debt Discount Current Long-term Total Balance at Dec 31, 2015 $ - $ (193) $ (193) Modification of warrants - - - Amortization expense - 51 51 Balance at June 30, 2016 $ - $ (142) $ (142) Deferred Debt Issuance Costs Current Long-term Total Balance at Dec 31, 2015 $ - $ (97) $ (97) Amortization expense - 27 27 Balance at June 30, 2016 $ - $ (70) $ (70) Long-term Debt, net at June 30, 2016 $ 2,629 $ 4,165 $ 6,794 Our interest expense for the three and six months ended June 30, 2016 and 2015 consisted of the following (in thousands): Three months Ended Six months Ended 2016 2015 2016 2015 Interest expense: Term loan $ 195 $ 251 $ 404 $ 512 Debt discount 25 33 51 63 Debt issue costs 13 17 27 34 Total interest expense $ 233 $ 301 $ 482 $ 609 Annual Calendar Year (in thousands) 2016 $ 1,287 2017 2,741 2018 2,978 Total $ 7,006 |
EQUITY FINANCING
EQUITY FINANCING | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
EQUITY FINANCING | NOTE 12 EQUITY FINANCING Our universal shelf registration statement on Form S-3 (File No. 333-210039) was declared effective by the U.S. Securities and Exchange Commission (“SEC”) on March 30, 2016. We may file with the SEC a prospectus supplement to our S-3 registration statement to sell common stock or other equity or debt securities, from time to time, in “registered direct” offerings, “at the market” offerings and certain other transactions. We expect that the net proceeds from such transactions, if any are completed, will be used for general corporate purposes, including working capital, research, development and marketing expenses, clinical trial expenditures and capital expenditures. |
COMMON STOCK WARRANTS
COMMON STOCK WARRANTS | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders Equity Note [Abstract] | |
COMMON STOCK WARRANTS | NOTE 13 - COMMON STOCK WARRANTS We have outstanding common stock purchase warrants (“warrants”) exercisable for 60 2.52 December 2020 2.52 10.0 June 30, 2016 2015 Number WAvg Number WAvg Outstanding, beginning 60 $ 2.52 60 $ 7.98 Issued - - - - Exercised - - - - Expired - - - - Modification - - - (5.46) Outstanding, ending 60 $ 2.52 60 $ 2.52 |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 14 - SHARE-BASED COMPENSATION Share-based Compensation We have four share-based compensation plans covering stock options and RSUs for our employees and directors. We measure our compensation cost related to share-based payment transactions based on fair value of the equity or liability instrument issued. For purposes of estimating the fair value of each stock option unit on the date of grant, we utilize the Black-Scholes option-pricing model. Option valuation models require the input of highly subjective assumptions including the expected volatility factor of the market price of our common stock (as determined by reviewing our historical public market closing prices). Our accounting for share-based compensation for RSUs is based on the market price of our common stock on the date of grant, less its exercise cost. Our share-based compensation expense recognized in the Company’s results of operations from all types of issued instruments comprised the following (in thousands): Three months Ended Six months Ended 2016 2015 2016 2015 Research and development expense: Stock options $ 43 $ 39 $ 85 $ 78 Restricted stock units - - - - Subtotal $ 43 $ 39 $ 85 $ 78 General and administrative expense: Stock options $ 77 $ 88 $ 155 $ 186 Restricted stock units 30 24 60 47 Subtotal $ 107 $ 112 $ 215 $ 233 Total $ 150 $ 151 $ 300 $ 311 Stock Option Award Plans We have two stock option plans in effect, and one stock option plan has expired by its terms, but pursuant to which stock options have been granted and remain outstanding. Six months Ended 2016 2015 Number Weighted Number of Weighted Outstanding, beginning 1,198 $ 15.67 911 $ 20.70 Granted - - - - Exercised - - - - Forfeited or expired - - (15) 26.25 Outstanding, ending 1,198 $ 15.67 896 $ 20.65 Options exercisable 938 $ 19.43 744 $ 24.10 There was no intrinsic value of option awards which were vested and outstanding at June 30, 2016. The intrinsic value of the option awards which were vested and outstanding at December 31, 2015 was $ 6 471 Restricted Stock Unit Award Plan We have a Restricted Stock Unit Award Plan (the “2014 RSU Plan”) for our employees and non-employee directors. Vesting of an RSU entitles the holder to receive a share of our common stock on a distribution date. The share-based compensation cost to be incurred on a granted RSU is the RSU’s fair value, which is the market price of our common stock on the date of grant, less its exercise cost. The compensation cost is amortized to expense over the vesting period of the RSU award. Six months Ended June 30, 2016 2015 (in thousands) Number Number of Number of Number of Outstanding, beginning 45 45 30 30 Granted 88 - 41 - Distributed (42) (42) (26) (26) Vested - 44 - 20 Forfeited or expired - - - - Outstanding, ending 91 47 45 24 Our 2014 RSU Plan was approved by shareholders on May 1, 2014 and permits the grant of up to 400 242 Information about the RSU grants under the 2014 RSU Plan is as follows: ⋅ On January 2, 2015, we awarded approximately 10.3 stock, for up to 40% 25 45 ⋅ On January 4, 2016, we awarded approximately 22.0 stock, for up to 40% 25 34 Information about the distribution of shares under the 2014 RSU Plan is as follows: ⋅ On January 2, 2015, 25.8 3.6 19.8 6 ⋅ On January 4, 2016, 41.2 1.2 2.4 42.4 32.8 9.6 23.8 |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 15 INCOME TAXES We account for income taxes under the liability method. Under this method, deferred income tax assets and liabilities are determined based on differences between financial reporting and income tax basis of assets and liabilities and are accounted for using the enacted income tax rates and laws that will be in effect when the differences are expected to reverse. Additionally, net operating loss and tax credit carryforwards are reported as deferred income tax assets. The realization of deferred income tax assets is dependent upon future earnings. A valuation allowance is required against deferred income tax assets if, based on the weight of available evidence, it is more likely than not that some or all of the deferred income tax assets may not be realized. At both June 30, 2016 and December 31, 2015, all our remaining net deferred income tax assets were offset by a valuation allowance due to uncertainties with respect to future utilization of net operating loss (“NOL”) carryforwards. If in the future it is determined that additional amounts of our deferred income tax assets would likely be realized, the valuation allowance would be reduced in the period in which such determination is made and an additional benefit from income taxes in such period would be recognized. We have approximately $ 52.8 155.2 34 2.0 2016 2035 1.2 which expire in the years 2024 through 2034 0.2 which expire in the years 2016 and 2017 |
EARNINGS PER SHARE ("EPS")
EARNINGS PER SHARE ("EPS") | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
EARNINGS PER SHARE ("EPS") | NOTE 16 EARNINGS PER SHARE (“EPS”) Basic EPS is computed by dividing net income or loss by the weighted average common shares outstanding during a period, including shares weighted related to vested Restricted Stock Units (“RSUs”) (see Note 14). Diluted EPS is based on the treasury stock method and computed based on the same number of shares used in the basic share calculation and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options and stock warrants, assuming the exercise of all in-the-money stock options and warrants. Common stock equivalents are excluded from the computation where their inclusion would be anti-dilutive. No such adjustments were made for 2016 and 2015 as the Company reported a net loss for both the six month and three month periods ending June 30 and including the effects of 1.3 1.0 Three months Ended Six months Ended 2016 2015 2016 2015 EPS basic and diluted Numerator: net loss $ (3,288) $ (2,663) $ (6,672) $ (1,424) Denominator (weighted): Common shares 11,834 9,833 11,833 9,811 Vested RSUs 24 14 14 9 Basic and diluted weighted average shares outstanding 11,858 9,847 11,847 9,820 EPS basic and diluted $ (0.28) $ (0.27) $ (0.56) $ (0.15) Excluded securities (non-weighted): Common shares issuable: Stock options 1,198 896 1,198 896 Nonvested RSUs 44 21 44 21 Common stock warrants 60 60 60 60 Total excluded common shares 1,302 977 1,302 977 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 17 COMMITMENTS AND CONTINGENCIES Purdue Pharma Complaints In April 2015, Purdue Pharma L.P., Purdue Pharmaceuticals L.P. and The P.F. Laboratories, Inc. (collectively, “Purdue”) commenced a patent infringement lawsuit against us and our Oxaydo product licensee Egalet US, Inc. and its parent Egalet Corporation in the United States District Court for the District of Delaware alleging our Oxaydo product infringes Purdue’s U.S. Patent No. 8,389,007 (the “ 007 patent”). In April 2016, Purdue commenced a second patent infringement lawsuit against us and Egalet in the United States District Court for the District of Delaware alleging our Oxaydo product infringes Purdue’s newly issued U.S. Patent No. 9,308,171 (the “171 Patent”). The actions regarding the 007 Patent and the 171 Patent are collectively referred to as the “Actions”. On April 6, 2016, we filed a petition for Inter Partes Review (the “IPR Review”) with the U.S. Patent and Trademark Office (“USPTO”) seeking to invalidate Purdue’s 007 Patent. On May 20, 2016, Purdue on behalf of themselves and certain affiliates, Egalet Corporation, on behalf of itself and its affiliates and we, on behalf of ourselves and our affiliates entered into a settlement agreement (the “Settlement Agreement”) to settle the Actions and the IPR Review. Under the Settlement Agreement the parties dismissed or withdrew the Actions, requested that the USPTO terminate the IPR Review and exchanged mutual releases. No payments were made under the Settlement Agreement. The Settlement Agreement also provides that Purdue will not, in the future, assert certain Purdue U.S. patents, including the 007 Patent, the 171 Patent and related technologies (the “Purdue Patents”) against any Acura Settlement Product or Egalet Settlement Product (except generally in an action or interference by Acura or Egalet challenging a Purdue Patent). Acura Settlement Products and Egalet Settlement Products are certain immediate-release and extended-release products, including Oxaydo. In addition, the Settlement Agreement provides that Purdue will not challenge, with certain exceptions, the Acura/Egalet Patents with respect to the Purdue Settlement Products (as defined below) and that Purdue provides Acura and/or Egalet certain waivers of non-patent marketing exclusivity with respect to Purdue Settlement Products. The Settlement Agreement also provides that Acura and Egalet will not, in the future, assert certain Acura and/or Egalet U.S. patents (the “Acura/Egalet Patents”), including Acura’s Aversion® Technology patents, against any Purdue Settlement Products (except generally in an action or interference by Purdue challenging an Acura/Egalet Patent). Purdue Settlement Products are certain immediate-release and extended-release products. In addition, the Settlement Agreement provides that Acura and Egalet will not challenge, with certain exceptions, the Purdue Patents with respect to the Acura Settlement Products and Egalet Settlement Products and that Acura and Egalet provide Purdue certain waivers of non-patent marketing exclusivity with respect to the Acura Settlement Products and Egalet Settlement Products. In addition, Purdue has certain rights to negotiate to exclusively distribute an authorized generic version of certain Egalet Settlement Products, including, in some circumstances, Oxaydo® and other products using Acura’s Aversion® Technology if licensed to Egalet. The Settlement Agreement specifically excludes our patents related to our Impede® and Limitx technologies from the scope of the Acura/Egalet Patents under the Settlement Agreement In December 2014, the Company entered into an agreement with Purdue Pharma L.P. to settle a patent interference action regarding certain intellectual property held by Acura (U.S. Patent No. 8,101,630). The dispute centered upon the issue of which company has priority in developing the invention. The parties agreed to forgo protracted litigation and the uncertainties arising therefrom by entering an agreement whereby the Company conceded Purdue Pharma’s claim of priority in exchange for certain financial consideration to us including an immediate non-refundable payment of $ 500 250 Reglan ® /Metoclopramide Litigation Halsey Drug Company, as predecessor to us, has been named along with numerous other companies as a defendant in cases filed in three separate state coordinated litigations pending in Pennsylvania, New Jersey and California, respectively captioned In re: Reglan®/Metoclopramide Mass Tort Litigation, Philadelphia County Court of Common Pleas, January Term, 2010, No. 01997; In re: Reglan Litigation, Superior Court of New Jersey, Law Division, Atlantic County, Case No. 289, Master Docket No. ATL-L-3865-10; and Reglan/Metoclopramide Cases, Superior Court of California, San Francisco County, Judicial Council Coordination Proceeding No. 4631, Superior Court No.: CJC-10-004631. In addition, Acura was served with a similar complaint by two individual plaintiffs in Nebraska federal court, which plaintiffs voluntarily dismissed in December 2014. In this product liability litigation against numerous pharmaceutical product manufacturers and distributors, including Acura, plaintiffs claim injuries from their use of the Reglan brand of metoclopramide and generic metoclopramide. In the Pennsylvania action, over 200 150 50 445 In the lawsuits filed to date, plaintiffs have not confirmed they ingested any of the generic metoclopramide manufactured by Acura. We discontinued manufacture and distribution of generic metoclopramide more than 19 years ago. In addition, we believe the June 23, 2011 decision by the U.S. Supreme Court in PLIVA v. Mensing (“Mensing In New Jersey, Generic Defendants, including Acura, filed dispositive motions based on the Mensing In Pennsylvania, and California, Generic Defendants, including Acura, also filed dispositive motions based on the Mensing In Pennsylvania, on November 18, 2011, the trial court denied Generic Defendants’ dispositive preemption motions, without prejudice. In July 2013, the Pennsylvania Superior Court issued an adverse decision, and a subsequent appeal to the Pennsylvania Supreme Court was denied. On December 16, 2014, the Generic Defendants filed a Joint Petition for Certiorari with the United States Supreme Court captioned Teva Pharmaceuticals USA, Inc. et al. v. Dorothy Bentley, et al. In California, the trial court entered a May 25, 2012 Order denying Generic Defendants’ dispositive preemption motions. The Generic Defendants’ appeals from this order were denied by the California appellate courts. In May 2014, the California Court denied a subsequent demurrer and motion to strike seeking dismissal of plaintiffs’ manufacturing defect and defective product claims to the extent that they are barred by federal preemption based upon the June 2013 Bartlett As any potential loss is neither probable nor estimable, we have not accrued for any potential loss related to these matters as of June 30, 2016 and we are presently unable to determine if any potential loss would be covered by our insurance carrier. Egalet Agreement On January 7, 2015, we and Egalet entered into a Collaboration and License Agreement (the “Egalet Agreement”) to commercialize Aversion Oxycodone (formerly known as Oxecta®) under our tradename Oxaydo. Oxaydo is approved by the FDA for marketing in the United States in 5 mg and 7.5 mg strengths. Under the terms of the Egalet Agreement, we transferred the approved New Drug Application, or NDA, for Oxaydo to Egalet and Egalet is granted an exclusive license under our intellectual property rights for development and commercialization of Oxaydo worldwide (the “Territory”) in all strengths, subject to our right to co-promote Oxaydo in the United States. Eaglet launched Oxaydo in the United States late in the third quarter of 2015. In accordance with the Egalet Agreement, we and Egalet have formed a joint steering committee to coordinate commercialization strategies and the development of product line extensions. Egalet will pay a significant portion of the expenses and we will pay for the other remaining portion of costs relating to (i) annual NDA PDUFA product fees, (ii) expenses of the FDA required post-marketing study for Oxaydo and (iii) expenses of clinical studies for product line extensions (additional strengths) of Oxaydo for the United States and Egalet will bear all of the expenses of development and regulatory approval of Oxaydo for sale outside the United States. Egalet is responsible for all manufacturing and commercialization activities in the Territory for Oxaydo. Subject to certain exceptions, Egalet will have final decision making authority with respect to all development and commercialization activities for Oxaydo, including pricing, subject to our co-promotion right. Egalet may develop Oxaydo for other countries and in additional strengths, in its discretion. At June 30, 2016, we have accrued approximately $100 thousand of cost sharing expenses of clinical studies for product line extensions (additional strengths) of Oxaydo for the United States under the Egalet Agreement and approximately $200 thousand of cost sharing expenses of the FDA required post-marketing study for Oxaydo under the Egalet Agreement. Facility Lease The Company leases administrative office space in Palatine, Illinois under a lease expiring March 31, 2017 25 |
INVESTMENTS IN MARKETABLE SEC25
INVESTMENTS IN MARKETABLE SECURITIES (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable securities | Investments in marketable securities consisted of the following: June 30, 2016 December 31, 2015 (in millions) (in millions) Marketable securities: Corporate bonds - maturing within 1 year $ 1.3 $ 3.1 Corporate bonds - maturing after 1 year and less than two years - 0.4 Exchange-traded funds 2.2 7.3 Total marketable securities $ 3.5 $ 10.8 |
Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value | The following tables provide a summary of the fair value and unrealized gains (losses) related to the Company’s available-for-sale securities: June 30, 2016 (in millions) Cost Gross Gross Fair Available-for-sale: Corporate bonds $ 1.3 $ - $ - $ 1.3 Exchange-traded funds 2.2 - - 2.2 Total - Current $ 3.5 $ - $ - $ 3.5 December 31, 2015 (in millions) Cost Gross Gross Fair Available-for-sale: Corporate bonds $ 3.6 $ - $ (0.1) $ 3.5 Exchange-traded funds 7.3 - - 7.3 Total - Current $ 10.9 $ - $ (0.1) $ 10.8 |
Fair Value, Assets Measured on Recurring Basis | Our assets measured at fair value or disclosed at fair value on a recurring basis as at June 30, 2016 and December 31, 2015 consisted of the following: June 30, 2016 (in millions) Total Level 1 Level 2 Level 3 Assets: Corporate bonds $ 1.3 $ - $ 1.3 $ - Exchange-traded funds 2.2 2.2 - - Total $ 3.5 $ 2.2 $ 1.3 $ - December 31, 2015 (in millions) Total Level 1 Level 2 Level 3 Assets: Corporate bonds $ 3.5 $ - $ 3.5 $ - Exchange-traded funds 7.3 7.3 - - Total $ 10.8 $ 7.3 $ 3.5 $ - |
INVENTORIES (Tables)
INVENTORIES (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories are summarized as follows: June 30, December 31, 2016 2015 (in thousands) Raw and packaging materials $ 98 $ - Finished goods 116 346 Total 214 346 Less: reserve for finished goods (32) (70) Net inventory $ 182 $ 276 |
Inventory Reserve | Inventory reserve activity during the six months ended June 30, 2016 and 2015 was as follows: 2016 2015 (in thousands) Reserve balance at January 1, $ 70 $ - Reserve expense raw and packaging materials - 260 Reserve expense finished goods 26 47 96 307 Inventory destruction raw and packaging materials - (260) Inventory destruction - finished goods (64) - Reserve balance at June 30, $ 32 $ 47 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property Plant and Equipment | . The estimated useful lives of the major classification of depreciable assets are: Building and improvements 10 - 40 years Land and improvements 20 - 40 years Machinery and equipment 7 - 10 years Scientific equipment 5 - 10 years Computer hardware and software 3 - 10 years |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Payables and Accruals [Abstract] | |
Accurued Expenses | Accrued expenses are summarized as follows: June 30, December 31, 2016 2015 (in thousands) Payroll, payroll taxes, and benefits $ 132 $ 101 Professional services 149 171 Franchise taxes 6 6 Property taxes 15 15 Marketing and promotion 40 115 Clinical, non-clinical and regulatory services 121 92 Cost sharing expenses 278 - Other fees and services 63 64 Total $ 804 $ 564 |
DEBT (Tables)
DEBT (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Schedule Of Fair Value Of Warrants | The fair value of the warrants was determined using the Black-Scholes option-pricing model. Significant assumptions used in the Black-Scholes model were: Expected dividend yield 0.0 % Risk-free interest rate 2.4 % Expected volatility 92 % Expected term (years) 7 |
Schedule of Debt | Our debt is summarized below (in thousands): Long-term Debt Current Long-term Total Balance at Dec 31, 2015 $ 2,320 $ 5,720 $ 8,040 Principal payments (1,034) - (1,034) Classification 1,343 (1,343) - Balance at June 30, 2016 $ 2,629 $ 4,377 $ 7,006 Debt Discount Current Long-term Total Balance at Dec 31, 2015 $ - $ (193) $ (193) Modification of warrants - - - Amortization expense - 51 51 Balance at June 30, 2016 $ - $ (142) $ (142) Deferred Debt Issuance Costs Current Long-term Total Balance at Dec 31, 2015 $ - $ (97) $ (97) Amortization expense - 27 27 Balance at June 30, 2016 $ - $ (70) $ (70) Long-term Debt, net at June 30, 2016 $ 2,629 $ 4,165 $ 6,794 |
Schedule of Interest Expense | Our interest expense for the three and six months ended June 30, 2016 and 2015 consisted of the following (in thousands): Three months Ended Six months Ended 2016 2015 2016 2015 Interest expense: Term loan $ 195 $ 251 $ 404 $ 512 Debt discount 25 33 51 63 Debt issue costs 13 17 27 34 Total interest expense $ 233 $ 301 $ 482 $ 609 |
Schedule Of Long Term Debt Future Principal Payments Year | The annual principal payments of the debt at June 30, 2016 are as follows: Annual Calendar Year (in thousands) 2016 $ 1,287 2017 2,741 2018 2,978 Total $ 7,006 |
COMMON STOCK WARRANTS (Tables)
COMMON STOCK WARRANTS (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders Equity Note [Abstract] | |
Schedule Of Common Stock Warrant Activity | Our warrant activity during the six month periods ended June 30, 2016 and 2015 is shown below (in thousands except price data): June 30, 2016 2015 Number WAvg Number WAvg Outstanding, beginning 60 $ 2.52 60 $ 7.98 Issued - - - - Exercised - - - - Expired - - - - Modification - - - (5.46) Outstanding, ending 60 $ 2.52 60 $ 2.52 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Summary Of Information About Non Vested Stock Options Disclosure Abstract [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Our share-based compensation expense recognized in the Company’s results of operations from all types of issued instruments comprised the following (in thousands): Three months Ended Six months Ended 2016 2015 2016 2015 Research and development expense: Stock options $ 43 $ 39 $ 85 $ 78 Restricted stock units - - - - Subtotal $ 43 $ 39 $ 85 $ 78 General and administrative expense: Stock options $ 77 $ 88 $ 155 $ 186 Restricted stock units 30 24 60 47 Subtotal $ 107 $ 112 $ 215 $ 233 Total $ 150 $ 151 $ 300 $ 311 |
Schedule of Share-based Compensation, Stock Options, Activity | Our stock option award activity during the six month periods ended June 30, 2016 and 2015 is shown below: Six months Ended 2016 2015 Number Weighted Number of Weighted Outstanding, beginning 1,198 $ 15.67 911 $ 20.70 Granted - - - - Exercised - - - - Forfeited or expired - - (15) 26.25 Outstanding, ending 1,198 $ 15.67 896 $ 20.65 Options exercisable 938 $ 19.43 744 $ 24.10 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | A summary of the grants under the RSU Plans consisted of the following: Six months Ended June 30, 2016 2015 (in thousands) Number Number of Number of Number of Outstanding, beginning 45 45 30 30 Granted 88 - 41 - Distributed (42) (42) (26) (26) Vested - 44 - 20 Forfeited or expired - - - - Outstanding, ending 91 47 45 24 |
EARNINGS PER SHARE ("EPS") (Tab
EARNINGS PER SHARE ("EPS") (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | A reconciliation of the numerators and denominators of basic and diluted EPS consisted of the following: Three months Ended Six months Ended 2016 2015 2016 2015 EPS basic and diluted Numerator: net loss $ (3,288) $ (2,663) $ (6,672) $ (1,424) Denominator (weighted): Common shares 11,834 9,833 11,833 9,811 Vested RSUs 24 14 14 9 Basic and diluted weighted average shares outstanding 11,858 9,847 11,847 9,820 EPS basic and diluted $ (0.28) $ (0.27) $ (0.56) $ (0.15) Excluded securities (non-weighted): Common shares issuable: Stock options 1,198 896 1,198 896 Nonvested RSUs 44 21 44 21 Common stock warrants 60 60 60 60 Total excluded common shares 1,302 977 1,302 977 |
LIQUIDITY MATTERS - Additional
LIQUIDITY MATTERS - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Nov. 30, 2016 | Jul. 31, 2016 | Dec. 31, 2015 | |
Restricted Cash and Investments, Total | $ 2,500 | $ 2,500 | |||||
Cash, Cash Equivalent And Marketable Securities | 4,300 | 4,300 | |||||
Working Capital | 1,200 | 1,200 | |||||
Retained Earnings (Accumulated Deficit), Total | (373,982) | (373,982) | $ (367,310) | ||||
Operating Income (Loss), Total | (3,079) | $ (2,398) | (6,217) | $ (886) | |||
Net Income (Loss) Attributable to Parent, Total | $ (3,288) | $ (2,663) | $ (6,672) | $ (1,424) | |||
Oxford term loan agreement [Member] | Scenario, Forecast [Member] | |||||||
Debt Instrument, Debt Default, Amount | $ 2,500 | ||||||
Oxford term loan agreement [Member] | Subsequent Event [Member] | |||||||
Unrestricted Cash and Cash Equivalents and marketable securities, Current | $ 3,400 | ||||||
Debt Instrument, Debt Default, Amount | $ 2,500 |
LICENSE, DEVELOPMENT, AND COM34
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 09, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Apr. 30, 2014 |
License Development and Commercialization Agreement [Line Items] | |||||
Agreement Termination Notice Description | Egalet may terminate the Egalet Agreement for convenience on 120 days prior written notice, which termination may not occur prior to the second anniversary of Egalet's launch of Oxaydo. Termination does not affect a party's rights accrued prior thereto, but there are no stated payments in connection with termination other than payments of obligations previously accrued. For all terminations (but not expiration), the Egalet Agreement provides for the transition of development and marketing of Oxaydo from Egalet to us, including the conveyance by Egalet to us of the trademarks and all regulatory filings and approvals relating to Oxaydo, and for Egalet's supply of Oxaydo for a transition period. | ||||
Retail Related Inventory, Total | $ 260 | $ 260 | |||
Amortization of Intangible Assets | $ 103 | 103 | |||
Proceeds from License Fees Received | $ 250 | ||||
Finite-Lived Intangible Assets, Gross | 1,500 | ||||
Pfizer Agreement | |||||
License Development and Commercialization Agreement [Line Items] | |||||
Payment for Termination | $ 2,000 | $ 2,000 | |||
Egalet Agreement | |||||
License Development and Commercialization Agreement [Line Items] | |||||
Minimum Net Sales Reaching Description | one-time $12.5 million milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year. | ||||
Licenses Revenue | $ 5,000 | ||||
Proceeds from Milestone Payment On Agreement | $ 2,500 |
REVENUE RECOGNITION - Additiona
REVENUE RECOGNITION - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2016 | Jun. 30, 2015 | Mar. 31, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Deferred Sales Inducements, Additions | $ 314 | |||||
Sales Returns Liability | $ 263 | $ 263 | $ 205 | |||
Other Revenue, Net | 133 | $ 0 | 233 | $ 0 | ||
Royalty Revenue, Total | 30 | 0 | 47 | 0 | ||
Cost of Revenue, Total | 255 | |||||
License and Services Revenue | $ 0 | $ 250 | $ 0 | $ 5,250 | ||
Allowance for Sales Returns [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Sales Returns and Allowances, Goods | $ 120 |
RESEARCH AND DEVELOPMENT ACTI36
RESEARCH AND DEVELOPMENT ACTIVITIES - Additional Information (Detail) - Contract Research Organization [Member] - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Contract Manufacturing Services Value | $ 200 | |
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross | $ 65 | $ 200 |
INVESTMENTS IN MARKETABLE SEC37
INVESTMENTS IN MARKETABLE SECURITIES - Summary of Investments in Marketable Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Marketable securities: | ||
Corporate bonds - maturing within 1 year | $ 1,300 | $ 3,100 |
Corporate bonds - maturing after 1 year and less than two years | 0 | 400 |
Total marketable securities | 3,516 | 10,837 |
Exchange-traded funds | ||
Marketable securities: | ||
Total marketable securities | $ 2,200 | $ 7,300 |
INVESTMENTS IN MARKETABLE SEC38
INVESTMENTS IN MARKETABLE SECURITIES - Fair Value and Unrealized Gains (Losses) related to the Company's Available-For-Sale Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Available-for-sale: | ||
Cost | $ 3,500 | $ 10,900 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | (100) |
Marketable securities (Note 7) | 3,516 | 10,837 |
Corporate Bonds | ||
Available-for-sale: | ||
Cost | 1,300 | 3,600 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | (100) |
Marketable securities (Note 7) | 1,300 | 3,500 |
Exchange-traded funds | ||
Available-for-sale: | ||
Cost | 2,200 | 7,300 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Marketable securities (Note 7) | $ 2,200 | $ 7,300 |
INVESTMENTS IN MARKETABLE SEC39
INVESTMENTS IN MARKETABLE SECURITIES - Assets Measured at Fair Value or Disclosed at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Assets: | ||
Total marketable securities | $ 3,516 | $ 10,837 |
Corporate bonds | ||
Assets: | ||
Total marketable securities | 1,300 | 3,500 |
Exchange-traded funds | ||
Assets: | ||
Total marketable securities | 2,200 | 7,300 |
Fair Value, Inputs, Level 1 | ||
Assets: | ||
Total marketable securities | 2,200 | 7,300 |
Fair Value, Inputs, Level 1 | Corporate bonds | ||
Assets: | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 1 | Exchange-traded funds | ||
Assets: | ||
Total marketable securities | 2,200 | 7,300 |
Fair Value, Inputs, Level 2 | ||
Assets: | ||
Total marketable securities | 1,300 | 3,500 |
Fair Value, Inputs, Level 2 | Corporate bonds | ||
Assets: | ||
Total marketable securities | 1,300 | 3,500 |
Fair Value, Inputs, Level 2 | Exchange-traded funds | ||
Assets: | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | ||
Assets: | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | Corporate bonds | ||
Assets: | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | Exchange-traded funds | ||
Assets: | ||
Total marketable securities | $ 0 | $ 0 |
INVESTMENTS IN MARKETABLE SEC40
INVESTMENTS IN MARKETABLE SECURITIES - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Accumulated Other Comprehensive Income (Loss) | ||
Investment In Marketable Securities [Line Items] | ||
Unrealized losses on securities | $ 26 | $ 65 |
INVENTORIES - Schedule of Inven
INVENTORIES - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 | Jun. 30, 2015 | Dec. 31, 2014 |
Inventory [Line Items] | ||||
Raw and packaging materials | $ 98 | $ 0 | ||
Finished goods | 116 | 346 | ||
Total | 214 | 346 | ||
Less: reserve for finished goods | (32) | (70) | $ (47) | $ 0 |
Net inventory | $ 182 | $ 276 |
INVENTORIES - Inventory Reserve
INVENTORIES - Inventory Reserve (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Inventory [Line Items] | ||
Reserve balance at January 1, | $ 70 | $ 0 |
Reserve expense - raw and packaging materials | 0 | 260 |
Reserve expense - finished goods | 26 | 47 |
Inventory Reserve Expense | 96 | 307 |
Inventory destruction - raw and packaging materials | 0 | (260) |
Inventory destruction - finished goods | (64) | 0 |
Reserve balance at June 30, | $ 32 | $ 47 |
PROPERTY, PLANT AND EQUIPMENT43
PROPERTY, PLANT AND EQUIPMENT (Detail) | 6 Months Ended |
Jun. 30, 2016 | |
Building and improvements | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 10 years |
Building and improvements | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 40 years |
Land and improvements | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 20 years |
Land and improvements | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 40 years |
Machinery and equipment | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 7 years |
Machinery and equipment | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 10 years |
Scientific equipment | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Scientific equipment | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 10 years |
Computer hardware and software | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Computer hardware and software | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 10 years |
PROPERTY, PLANT AND EQUIPMENT -
PROPERTY, PLANT AND EQUIPMENT - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation | $ 68 | $ 59 | |
Property, Plant and Equipment, Gross | 2,817 | $ 2,754 | |
Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment | $ 1,808 | $ 1,741 |
ACCRUED EXPENSES (Detail)
ACCRUED EXPENSES (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Accounts Payable and Accrued Liabilities [Line Items] | ||
Payroll, payroll taxes, and benefits | $ 132 | $ 101 |
Professional services | 149 | 171 |
Franchise taxes | 6 | 6 |
Property taxes | 15 | 15 |
Marketing and promotion | 40 | 115 |
Clinical, non-clinical and regulatory services | 121 | 92 |
Cost sharing expenses | 278 | 0 |
Other fees and services | 63 | 64 |
Total | $ 804 | $ 564 |
DEBT - Fair Value of Warrants u
DEBT - Fair Value of Warrants using the Black-Scholes option-pricing model (Detail) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Of Warrants [Line Items] | |
Expected dividend yield | 0.00% |
Risk-free interest rate | 2.40% |
Expected volatility | 92.00% |
Expected term (years) | 7 years |
DEBT - Summary of Debt (Detail)
DEBT - Summary of Debt (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Long-term Debt | ||
Balance at Dec 31, 2015 | $ 8,040 | |
Classification | 0 | |
Balance at June 30, 2016 | 7,006 | |
Debt Discount | ||
Balance at Dec 31, 2015 | (193) | |
Modification of warrants | 0 | $ 33 |
Amortization expense | 51 | |
Balance at June 30, 2016 | (142) | |
Deferred Debt Issuance Costs | ||
Balance at Dec 31, 2015 | (97) | |
Amortization expense | 27 | |
Balance at June 30, 2016 | (70) | |
Long-term Debt, net at June 30, 2016 | 6,794 | |
Loan Agreement [Member] | ||
Long-term Debt | ||
Principal payments | (1,034) | |
Long-term [Member] | ||
Long-term Debt | ||
Balance at Dec 31, 2015 | 5,720 | |
Classification | (1,343) | |
Balance at June 30, 2016 | 4,377 | |
Debt Discount | ||
Balance at Dec 31, 2015 | (193) | |
Modification of warrants | 0 | |
Amortization expense | 51 | |
Balance at June 30, 2016 | (142) | |
Deferred Debt Issuance Costs | ||
Balance at Dec 31, 2015 | (97) | |
Amortization expense | 27 | |
Balance at June 30, 2016 | (70) | |
Long-term Debt, net at June 30, 2016 | 4,165 | |
Long-term [Member] | Loan Agreement [Member] | ||
Long-term Debt | ||
Principal payments | 0 | |
Current [Member] | ||
Long-term Debt | ||
Balance at Dec 31, 2015 | 2,320 | |
Classification | 1,343 | |
Balance at June 30, 2016 | 2,629 | |
Debt Discount | ||
Balance at Dec 31, 2015 | 0 | |
Modification of warrants | 0 | |
Amortization expense | 0 | |
Balance at June 30, 2016 | 0 | |
Deferred Debt Issuance Costs | ||
Balance at Dec 31, 2015 | 0 | |
Amortization expense | 0 | |
Balance at June 30, 2016 | 0 | |
Long-term Debt, net at June 30, 2016 | 2,629 | |
Current [Member] | Loan Agreement [Member] | ||
Long-term Debt | ||
Principal payments | $ (1,034) |
DEBT - Interest Expense (Detail
DEBT - Interest Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Interest expense: | ||||
Term Loan | $ 195 | $ 251 | $ 404 | $ 512 |
Debt discount | 25 | 33 | 51 | 63 |
Debt issue costs | 13 | 17 | 27 | 34 |
Total interest expense | $ 233 | $ 301 | $ 482 | $ 609 |
DEBT - Long-Term Debt (Detail)
DEBT - Long-Term Debt (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Debt Instrument [Line Items] | ||
2,016 | $ 1,287 | |
2,017 | 2,741 | |
2,018 | 2,978 | |
Total | $ 7,006 | $ 8,040 |
DEBT - Additional Information (
DEBT - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Jan. 07, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2013 | Dec. 27, 2013 |
Debt Instrument [Line Items] | ||||||||
Debt instrument principal amount | $ 10,000 | |||||||
Debt default long term debt percentage | 13.35% | |||||||
Debt instrument, fee amount | $ 50 | $ 50 | ||||||
Debt consulting placement fee | 100 | |||||||
Debt related commitment fees and debt issuance costs | 13 | $ 17 | 27 | $ 34 | ||||
Debt instrument unamortized discount | 142 | 142 | $ 193 | |||||
Warrants to purchase common stock | 60 | 60 | ||||||
Debt instrument Cash Maintenance | $ 2,500 | |||||||
Repayments of Debt | 1,034 | $ 573 | ||||||
Additions To Debt Instrument Unamortized Discount | 0 | $ 33 | ||||||
Interest Payable, Current | 49 | 49 | $ 0 | |||||
Long-term Debt | $ 6,794 | $ 6,794 | ||||||
Loan Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, interest rate, stated percentage | 8.35% | |||||||
Debt Instrument, Maturity Date | Dec. 1, 2018 | |||||||
Repayments of Debt | $ 5,000 | |||||||
Debt Instrument, Periodic Payment | $ 260 | |||||||
Debt instrument, periodic payment, principal | $ 1,034 | |||||||
Debt Instrument, Interest Rate, Effective Percentage | 10.16% | 10.16% | ||||||
Term Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest Payable, Current | $ 477 | $ 477 | ||||||
Long-term Debt | 7,000 | 7,000 | ||||||
Maximum [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.98 | $ 7.98 | ||||||
Maximum [Member] | Loan Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.98 | |||||||
Minimum [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 | ||||||
Minimum [Member] | Loan Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | |||||||
Warrant | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument unamortized discount | $ 400 | $ 400 | ||||||
Warrants to purchase common stock | 60 | 60 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 | $ 2.52 | |||||
Warrants, expiry date | December 2,020 | |||||||
Additions To Debt Instrument Unamortized Discount | $ 33 | |||||||
Warrant | Loan Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.98 | $ 7.98 | ||||||
Warrants, expiry date | December 27, 2020 | |||||||
First Revenue Event Occurs | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument periodic payment terms balloon payment to be paid | $ 795 | $ 795 | ||||||
Prior To December 27 2015 | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument prepayment percentage | 1.00% | |||||||
Oxford Finance LLC [Member] | Loan Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, periodic payment, principal | $ 3,000 |
COMMON STOCK WARRANTS - Schedul
COMMON STOCK WARRANTS - Schedule Of Common Stock Warrant Activity (Detail) - Warrant [Member] - $ / shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Number of Options | ||
Number of Options Outstanding, beginning | 60 | 60 |
Number of Options, Issued | 0 | 0 |
Number of Options, Exercised | 0 | 0 |
Number of Options, Expired | 0 | 0 |
Number of Options, Modification | 0 | 0 |
Number of Options Outstanding, ending | 60 | 60 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, beginning | $ 2.52 | $ 7.98 |
Weighted Average Exercise Price, Issued | 0 | 0 |
Weighted Average Exercise Price, Exercised | 0 | 0 |
Weighted Average Exercise Price, Expired | 0 | 0 |
Weighted Average Exercise Price, Modification | 0 | (5.46) |
Weighted Average Exercise Price, ending | $ 2.52 | $ 2.52 |
COMMON STOCK WARRANTS - Additio
COMMON STOCK WARRANTS - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Millions | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2013 | |
Class of Warrant or Right [Line Items] | |||
Common stock warrant exercisable outstanding, shares | 60 | ||
Secured Debt | $ 10 | ||
Warrant | |||
Class of Warrant or Right [Line Items] | |||
Common stock warrant exercisable outstanding, shares | 60 | ||
Common stock Warrant expiration date | December 2,020 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 |
SHARE-BASED COMPENSATION - Reco
SHARE-BASED COMPENSATION - Recognition of Share-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
SHARE-BASED COMPENSATION - Recognition of Share-Based Compensation Expense [Line Items] | ||||
Research and development expense | $ 1,403 | $ 511 | $ 2,417 | $ 1,475 |
Total | 150 | 151 | 300 | 311 |
Research and Development Expense [Member] | ||||
SHARE-BASED COMPENSATION - Recognition of Share-Based Compensation Expense [Line Items] | ||||
Research and development expense | 43 | 39 | 85 | 78 |
General and Administrative Expense [Member] | ||||
SHARE-BASED COMPENSATION - Recognition of Share-Based Compensation Expense [Line Items] | ||||
General and administrative expense | 107 | 112 | 215 | 233 |
Employee Stock Option [Member] | Research and Development Expense [Member] | ||||
SHARE-BASED COMPENSATION - Recognition of Share-Based Compensation Expense [Line Items] | ||||
Research and development expense | 43 | 39 | 85 | 78 |
Employee Stock Option [Member] | General and Administrative Expense [Member] | ||||
SHARE-BASED COMPENSATION - Recognition of Share-Based Compensation Expense [Line Items] | ||||
General and administrative expense | 77 | 88 | 155 | 186 |
Restricted Stock Units (RSUs) [Member] | Research and Development Expense [Member] | ||||
SHARE-BASED COMPENSATION - Recognition of Share-Based Compensation Expense [Line Items] | ||||
Research and development expense | 0 | 0 | 0 | 0 |
Restricted Stock Units (RSUs) [Member] | General and Administrative Expense [Member] | ||||
SHARE-BASED COMPENSATION - Recognition of Share-Based Compensation Expense [Line Items] | ||||
General and administrative expense | $ 30 | $ 24 | $ 60 | $ 47 |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock Option Award Activity (Detail) - Employee Stock Option [Member] - $ / shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
SHARE-BASED COMPENSATION - Stock Option Award Activity [Line Items] | ||
Number of Options Outstanding, beginning | 1,198 | 911 |
Number of Options, Granted | 0 | 0 |
Number of Options, Exercised | 0 | 0 |
Number of Options, Forfeited or expired | 0 | (15) |
Number of Options Outstanding, ending | 1,198 | 896 |
Number of Options exercisable | 938 | 744 |
Weighted Average Exercise Price, beginning | $ 15.67 | $ 20.7 |
Weighted Average Exercise Price, Granted | 0 | 0 |
Weighted Average Exercise Price, Exercised | 0 | 0 |
Weighted Average Exercise Price, Forfeited or expired | 0 | 26.25 |
Weighted Average Exercise Price, ending | 15.67 | 20.65 |
Weighted Average Exercise Price, Options exercisable | $ 19.43 | $ 24.1 |
SHARE-BASED COMPENSATION - Summ
SHARE-BASED COMPENSATION - Summary of RSU Plan (Detail) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Restricted Stock Units [Member] | ||
Share Based Compensations Summary Of RSUs Plan [Line Items] | ||
Outstanding, beginning | 45 | 30 |
Granted | 88 | 41 |
Distributed | (42) | (26) |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 91 | 45 |
Vested Restricted Stock Units [Member] | ||
Share Based Compensations Summary Of RSUs Plan [Line Items] | ||
Outstanding, beginning | 45 | 30 |
Granted | 0 | 0 |
Distributed | (42) | (26) |
Vested | 44 | 20 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 47 | 24 |
SHARE-BASED COMPENSATION - Addi
SHARE-BASED COMPENSATION - Additional Information (Detail) - USD ($) | Jan. 04, 2016 | Jan. 02, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jan. 02, 2015 | Jan. 04, 2016 | Jan. 04, 2016 | Dec. 31, 2015 | May 01, 2014 |
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value | $ 0 | $ 6,000 | |||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 471,000 | ||||||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 2,400 | ||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 23,800 | ||||||||
Total Restricted Stock Unit Award Plan [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 42,400 | ||||||||
2014 Restricted Stock Unit Award Plan [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 400,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Purchased for Award | 242,000 | ||||||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 3,600 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 25,800 | 41,200 | 1,200 | ||||||
2014 Restricted Stock Unit Award Plan [Member] | Settled In Cash [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 9,600 | 6,000 | |||||||
2014 Restricted Stock Unit Award Plan [Member] | Convertible Common Stock [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 32,800 | 19,800 | |||||||
2014 Restricted Stock Unit Award Plan [Member] | Four Non Employee Directors [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 22,000 | 10,300 | |||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 34,000 | $ 45,000 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | stock, for up to 40% | stock, for up to 40% | |||||||
2014 Restricted Stock Unit Award Plan [Member] | Four Non Employee Directors [Member] | Share-based Compensation Award, Tranche One [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | 25.00% |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Detail) - USD ($) $ in Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Line Items] | ||
Federal income tax benefits | $ 52.8 | |
Federal NOLs | $ 155.2 | |
U.S. statutory tax rate | 34.00% | |
State income tax benefits | $ 2 | |
Federal Research and Development | ||
Income Tax Disclosure [Line Items] | ||
Research and development tax credits | 1.2 | |
Research and development expiration period | which expire in the years 2024 through 2034 | |
Indiana State Research and Development | ||
Income Tax Disclosure [Line Items] | ||
Research and development tax credits | $ 0.2 | |
Research and development expiration period | which expire in the years 2016 and 2017 | |
Maximum | ||
Income Tax Disclosure [Line Items] | ||
NOL expiration year | 2,035 | |
Minimum | ||
Income Tax Disclosure [Line Items] | ||
NOL expiration year | 2,016 |
EARNINGS PER SHARE ("EPS") - Re
EARNINGS PER SHARE ("EPS") - Reconciliation of Numerators and Denominators of Basic and Diluted EPS (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
EPS - basic and diluted | ||||
Numerator: net loss | $ (3,288) | $ (2,663) | $ (6,672) | $ (1,424) |
Denominator (weighted): | ||||
Common shares | 11,834 | 9,833 | 11,833 | 9,811 |
Vested RSUs | 24 | 14 | 14 | 9 |
Basic and diluted weighted average shares outstanding | 11,858 | 9,847 | 11,847 | 9,820 |
EPS - basic and diluted | $ (0.28) | $ (0.27) | $ (0.56) | $ (0.15) |
Common shares issuable: | ||||
Total excluded common shares | 1,302 | 977 | 1,302 | 977 |
Stock options | ||||
Common shares issuable: | ||||
Total excluded common shares | 1,198 | 896 | 1,198 | 896 |
Nonvested RSUs | ||||
Common shares issuable: | ||||
Total excluded common shares | 44 | 21 | 44 | 21 |
Common stock warrants | ||||
Common shares issuable: | ||||
Total excluded common shares | 60 | 60 | 60 | 60 |
EARNINGS PER SHARE ("EPS") - Ad
EARNINGS PER SHARE ("EPS") - Additional Information (Detail) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 1,302 | 977 | 1,302 | 977 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Detail) $ in Thousands | 1 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2014USD ($) | |
Commitments and Contingencies Disclosure [Line Items] | |||
Accrued Cost Sharing Expenses Clinical Studies | $ 100 | ||
Accrued Cost Sharing Expenses, Post Marketing Study | $ 200 | ||
Purdue Pharma [Member] | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Litigation Settlement, Expense | $ 250 | $ 500 | |
Pennsylvania State | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Number of lawsuits filed | 200 | ||
New Jersey State | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Number of lawsuits filed | 150 | ||
Number of lawsuits served | 50 | ||
California State | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Number of plaintiffs served in a single complaint | 445 | ||
Palatine Lllinois | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Leases administrative office space | $ 25 | ||
Lease expiring date | March 31, 2017 |